At the present time, physicians place an introducer sheath through the skin of a patient to access that patient's vascular system. Two usual places to gain access are through the skin at the groin to enter the femoral artery and through the skin in the wrist to access the radial artery. After the introducer sheath is placed through the skin, the physician will typically use a suture to fasten the proximal end of the introducer sheath to the patient's skin. That process requires the opening of an additional package that contains the suture thread and a needle, and also requires skin penetration that can be somewhat painful for the patient and has the possibility of infection.
In U.S. Pat. No. 5,827,239, S. F. Bierman has shown an adhesive attachment to the skin onto which certain catheters could be connected. One disadvantage of Bierman's attachment means is that it requires a separate sterile package to be opened in addition to the sterile package containing the introducer sheath. This requires additional procedure time and the separate sterilization of two different packages which increases costs. Another disadvantage of the Bierman device is that it is not as secure a holding means for a hemostasis valve as would be achieved if the adhesive attachment means was joined to the hemostasis valve of the introducer sheath. A highly reliable and rapid attachment means to secure the proximal end of the introducer sheath to the patient's skin would be an important improvement in the design of introducer sheaths.
Most of the introducer sheaths in use at this time have their side tube in a fixed position relative to the sheath's hemostasis valve. This is sometimes disadvantageous since the physician may wish for the side arm to be rotated to an alternate position. As described by J. E. Biche in U.S. Pat. No. 5,944,697, the prior art teaches a sheath design with a suture ring that can rotate relative to the sheath's hemostasis valve. However, as described above, there are certain disadvantages for an introducer sheath that that must be attached to the skin by means of a suture. What has not yet been available for the interventional cardiologist is the unique combination of an adhesive attachment means to attach the sheath's hemostasis valve to the patient's skin combined with a means to rotate the sheath's side tube relative to the adhesive connection means.